U.S. patent application number 10/727037 was filed with the patent office on 2004-10-28 for pcr sample preparation holder and method.
This patent application is currently assigned to SMITHS DETECTION-EDGEWOOD, INC.. Invention is credited to Brown, Drew Chapman, Clasen, Eric Scott, Holmes, Carrie Lynn, Howland, Tiffany, Miller, Lisa, Pallo, Richard Karl, Rello, Michael Joseph.
Application Number | 20040214200 10/727037 |
Document ID | / |
Family ID | 33302833 |
Filed Date | 2004-10-28 |
United States Patent
Application |
20040214200 |
Kind Code |
A1 |
Brown, Drew Chapman ; et
al. |
October 28, 2004 |
PCR sample preparation holder and method
Abstract
A simplified Polymerase Chain Reaction (PCR) sample preparation
apparatus and method of using a PCR sample preparation for both
liquid and dry samples. A portable apparatus comprising a handle
removably attached to a wand assembly. The handle includes a cover
and a swab with an absorbent material. The wand assembly includes a
buffer container for a buffer that is ruptured by a spike when the
holder is inserted into the wand assembly. The apparatus may
include a waste container removably attached to a tube comprising a
plunger, a safety clip to prevent the plunger from depressing, and
a port for introduction of a liquid sample. A filter on the waste
container collects a specimen of the liquid sample for preparation
as described above.
Inventors: |
Brown, Drew Chapman;
(Towson, MD) ; Holmes, Carrie Lynn; (Bel Air,
MD) ; Clasen, Eric Scott; (Hillsborough, NJ) ;
Pallo, Richard Karl; (New Hope, PA) ; Rello, Michael
Joseph; (Harleysville, PA) ; Miller, Lisa;
(Cockeysville, MD) ; Howland, Tiffany; (Pasadena,
MD) |
Correspondence
Address: |
FOLEY AND LARDNER
SUITE 500
3000 K STREET NW
WASHINGTON
DC
20007
US
|
Assignee: |
SMITHS DETECTION-EDGEWOOD,
INC.
|
Family ID: |
33302833 |
Appl. No.: |
10/727037 |
Filed: |
December 4, 2003 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60430994 |
Dec 4, 2002 |
|
|
|
Current U.S.
Class: |
435/6.18 ;
435/287.2; 435/6.1; 435/91.2 |
Current CPC
Class: |
B01L 2400/0683 20130101;
G01N 2001/028 20130101; B01L 2200/026 20130101; B01L 2400/0478
20130101; B01L 3/5029 20130101; B01L 2300/0672 20130101; B01L
2200/16 20130101; B01L 7/52 20130101; B01L 2300/042 20130101; B01L
2200/082 20130101 |
Class at
Publication: |
435/006 ;
435/091.2; 435/287.2 |
International
Class: |
C12Q 001/68; C12P
019/34; C12M 001/34 |
Claims
What is claimed is:
1. An apparatus for preparing samples for Polymerase Chain Reaction
analysis comprising: a handle having a chamber; a swab attached to
an end of the handle, wherein the swab includes a stabilized
reagent in the chamber and a sample tube extending from an end of
the chamber; a wand assembly including a buffer container at an end
of a shaft and a stand at another end of the shaft; and wherein the
handle is configured to be attached to the wand assembly.
2. The apparatus of claim 1, wherein the buffer container includes
a film covering one end of the container.
3. The apparatus of claim 1, further comprising a spike positioned
in the wand assembly and configured to rupture the buffer container
to allow a buffer to exit the buffer container and flow into the
chamber.
4. The apparatus of claim 1, wherein the chamber includes
vents.
5. The apparatus of claim 1, wherein the handle removably attaches
to the wand assembly by the swab inserting into the shaft of the
wand assembly.
6. The apparatus of claim 5, wherein a cover of the handle is
configured to detach from the swab when the swab is attached to the
wand assembly.
7. The apparatus of claim 1, wherein the wand assembly includes an
extendable grip.
8. The apparatus of claim 1, wherein the stand is configured to
attach to a slot in a hand-held detector for biological
materials.
9. The apparatus of claim 1, wherein the handle and wand assembly
are configured to be portable.
10. The apparatus of claim 1, further comprising an absorbent
material attached at an end of the swab.
11. The apparatus of claim 10, wherein the absorbent material is
held in place by a retaining ring.
12. The apparatus of claim 10, wherein a mesh covers the absorbent
material.
13. The apparatus of claim 10, further comprising a mesh underneath
the absorbent material.
14. The apparatus of claim 10, wherein the absorbent material
comprises IsoCode paper.
15. An apparatus for preparing liquid samples comprising: a waste
container, a tube with a port for introduction of a liquid sample
and a plunger for pushing the liquid sample into the waste
container; and wherein the tube is removably attached to the waste
container.
16. The apparatus of claim 13, further comprising a safety clip
removably attached to the plunger and configured to prevent the
plunger from depressing during introduction of a liquid sample into
the port.
17. The apparatus of claim 13, wherein the waste container includes
a vent.
18. The apparatus of claim 13, further comprising a handgrip on the
waste container, wherein the handgrip is configured to mate with a
gloved hand.
19. The apparatus of claim 13, wherein the apparatus is configured
to be portable for use in the field.
20. The apparatus of claim 13, wherein the waste container includes
a well for attaching the tube to the waste container.
21. The apparatus of claim 13 wherein the waste container includes
Watersorb.
22. The apparatus of claim 18, wherein the well is configured to
receive a swab mounted on a handle, wherein the swab is adapted to
collect a specimen of a prepared sample.
23. The apparatus of claim 18, further comprising a buffer
compartment at an end of the plunger; and a spike positioned in the
tube so that the spike ruptures the buffer compartment when the
plunger is depressed.
24. The apparatus of claim 20, further comprising a filter
positioned in the well to receive a buffer and the liquid sample,
wherein the filter is adapted to collect a specimen of the prepared
liquid sample.
25. A biological sampling method for dry and/or processed samples,
comprising the following steps: providing a handle containing an
absorbent material and stabilized reagent and wiping the absorbent
material over a test surface; and providing a wand assembly and
inserting the handle into the wand assembly, thereby rupturing a
buffer container to enable a buffer to be released through the
absorbent material and into a chamber for mixing with the reagent
and filling a sample tube.
26. The method of claim 22, further comprising the steps of:
sealing the chamber by fully inserting a swab of the handle into
the wand assembly; extending a grip on the wand; removing a cover
on the swab, and "whipping" the wand twice; retracting the grip on
the wand; and inserting the wand into a hand-held detector for
biological materials.
27. The method of claim 22, wherein the buffer container is
ruptured by rupturing a film covering one end of the container.
28. The method of claim 22, wherein the absorbent material
comprises IsoCode paper.
29. The method of claim 22, wherein the absorbent material is
covered by a mesh.
30. The method of claim 22 further comprising a mesh under the
absorbent material.
31. A biological sampling method for liquid samples comprising the
following steps: providing a waste container having a plunger and a
port, and introducing the liquid sample into the port; removing a
safety clip and depressing the plunger up to a stop on the plunger,
to concentrate particles in the liquid sample onto a filter, such
that a spike ruptures a liquid container and the plunger pumps a
buffer through the filter and into the waste container to wash
inhibitors off the particles, and such that a sample collects on
the filter; removing the plunger and discarding the plunger; and
providing a swab and inserting the swab to pick up the sample from
the filter in the waste container.
32. The method of claim 27, wherein the swab with the
substantially-dry sample thereon is tested with a biological
sampling method comprising the following steps: providing a handle
containing an absorbent material and stabilized reagent and wiping
the absorbent material over a test surface; and providing a wand
assembly and inserting the handle into the wand assembly, thereby
rupturing a buffer container to enable a buffer to be released
through the absorbent material and into a chamber for mixing with
the reagent and filling a sample tube.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and the benefit of U.S.
Provisional Patent Application No. 60/430,994 filed on Dec. 4,
2002, incorporated by reference herein in its entirety.
BACKGROUND
[0002] The present invention relates to a simplified Polymerase
Chain Reaction (PCR) sample preparation consumable comprising a
handle removably attachable to a wand assembly for dry or processed
samples. The present invention also relates to a method of
biological sampling for dry, liquid or processed samples.
[0003] The present invention pertains to preparing samples for
Polymerase Chain Reaction (PCR) analysis in the field.
[0004] Conventional PCR analysis is a complex procedure, requiring
a series of steps with laboratory equipment. Conventional PCR
analysis requires skill exceeding that of most field personnel.
[0005] Conventional PCR analysis typically requires samples to be
processed or treated prior to PCR analysis. A drawback to the
sample processing is that it involves at least three complex steps.
First, inhibitors such as humic acids and metals in the environment
are removed. Second, the sample is filtered and concentrated.
Third, a combination of reagents required by the PCR assay must be
added to the sample.
[0006] Another drawback of conventional PCR analysis is the
apparatus is not portable. Typically such conventional analysis is
done at a lab, not in the field.
SUMMARY OF THE INVENTION
[0007] An object of the present invention is to provide an
apparatus and method to process a sample for PCR analysis.
According to an embodiment of the present invention, the apparatus
is simplified so that a non-technical person with a minimum of
training can perform PCR sample preparation in the field.
[0008] According to another embodiment of the present invention, an
apparatus for preparing samples for PCR analysis includes a handle
and a wand assembly. The handle is comprised of a swab attached to
an end of the handle, and the swab includes a stabilized reagent
bead located in a chamber and a sample tube that extends from an
end of the chamber. The wand assembly includes a buffer container
at an end of a shaft. A stand is located at another end of the
shaft of the wand assembly. The handle is configured to attach to
the wand assembly.
[0009] According to another embodiment of the present invention, an
apparatus for preparing liquid samples includes a waste container
and a tube. The tube includes a port for introduction of a liquid
sample, and a plunger for pushing the liquid sample into the waste
container. The tube is removably attached to the waste
container.
[0010] According to another aspect of the present invention, a
biological sampling method for dry and/or processed samples
includes the steps of providing a handle containing an absorbent
material and stabilized reagent. The method further includes wiping
the absorbent material over a test surface, providing a wand
assembly and inserting the handle into the wand assembly, thus
rupturing a buffer container. Rupturing the buffer container
releases a buffer through the absorbent material and into a chamber
for mixing with the reagents and filling a sample tube.
[0011] According to another aspect of the present invention, a
biological sampling method for liquid samples includes the steps of
providing a waste container having a plunger and a port and
introducing the liquid sample into the port. The biological
sampling method further includes removing a safety clip and
depressing the plunger up to a stop on the plunger, to concentrate
particles in the liquid sample onto a filter. A spike ruptures a
liquid container and the plunger pumps a buffer through the filter
and into the waste container, washing inhibitors off the particles,
such that a sample collects on the filter. The biological sampling
method further includes removing the plunger and discarding the
plunger, providing a swab and inserting the swab to pick up the
sample from the filter in the waste container.
[0012] The apparatus for preparing samples for PCR analysis may,
according to an embodiment of the present invention, be easily
portable for use in the field.
[0013] The apparatus for preparing samples for PCR analysis may,
according to another embodiment of the present invention, prepare
liquid or dry samples.
[0014] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and exemplary only and are not restrictive of the invention as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] These and other features, aspects, and advantages of the
present invention will become apparent from the following
description, appended claims, and the accompanying exemplary
embodiments shown in the drawings, which are briefly described
below.
[0016] FIG. 1 is a perspective view of an embodiment of an
apparatus for preparing samples for Polymerase Chain Reaction
analysis according to the present invention.
[0017] FIG. 2 is a cross-sectional view of an apparatus of FIG.
1.
[0018] FIG. 3 is a view of the handle of the apparatus of FIG.
1.
[0019] FIG. 4 is a cross-sectional view of the handle of the
apparatus of FIG. 1.
[0020] FIG. 5 is a cross-sectional view of the apparatus of FIG.
1.
[0021] FIG. 6 is a view of the apparatus of FIG. 1.
[0022] FIG. 7 is a cross-sectional view of the apparatus of FIG.
1.
[0023] FIG. 8 is a cross-sectional view of the apparatus of FIG.
1.
[0024] FIG. 9 is a perspective view of another embodiment of the
apparatus according to the present invention.
[0025] FIG. 10 is a view of the apparatus of FIG. 9.
[0026] FIG. 11 is a cross-sectional view of the apparatus of FIG.
9.
[0027] FIG. 12 is an exploded view of the apparatus of FIG. 9.
[0028] FIG. 13 is a cross-sectional view of the apparatus of FIG.
9.
[0029] FIG. 14 is a view of the apparatus of FIG. 9.
[0030] FIGS. 15a to 15e are a view of the method of using an
embodiment of the apparatus according to the present invention.
[0031] FIGS. 16a to 16fare a view of a method of using another
embodiment of the apparatus according to the present invention.
DESCRIPTION
[0032] Hereinafter, embodiments of the present invention will be
described with reference to the attached drawings.
[0033] An apparatus 1 for preparing a sample for PCR analysis is
disclosed in FIG. 1. The apparatus 1 includes a handle 2 removably
attached to a wand assembly 10. The handle 2 includes a cover 9
attached to a swab 7. The swab 7 includes an absorbent material 3
at an end of the swab 7 further from the cover 9. The wand assembly
10 includes an extendable grip 14, a shaft 16 and a stand 15 at an
end of the wand assembly 10.
[0034] A stabilized reagent 4, as can be seen in FIGS. 2, and 4-6,
is located in a chamber 5. The chamber 5 is located in the swab 7
of the handle 2. The swab 7 further includes a sample tube 6
extending from an end of the chamber 5. The sample tube 6 collects
a sample of a prepared substance for further analyzing.
[0035] As can be seen in FIGS. 2, 5 and 6, the wand assembly 10
further includes a buffer container 11. The buffer container 11 is
positioned at an end of the shaft 16. The buffer container 11 may
contain a buffer for use in analyzing a sample of a substance. The
buffer container 11 includes a film 12. The film 12 covers an end
of the buffer container 11.
[0036] As shown in FIG. 6, a spike 13 is positioned in the wand
assembly 10. The spike 13 is configured to rupture the buffer
container 11 to allow a buffer to exit the buffer container 11 and
flow through the absorbent material 3 and into the chamber 5 and/or
the sample tube 6. The spike 13 ruptures the film 12 of the buffer
container 11 when the handle 2 is attached to the wand assembly
10.
[0037] The absorbent material 3 of the handle 2 may be IsoCode
paper. The absorbent material 3 may be held onto the swab 7 by a
retaining ring 65. The absorbent material 3 may be wiped over a
test surface to collect a sample of a substance that is to be
prepared for analysis. The absorbent material 3 may further be
covered by a mesh 8, or the mesh 8 may be under the absorbent
material 3.
[0038] The handle 2 and wand assembly 10 are removably attachable.
The handle 2 attaches to the wand assembly 10 by inserting the swab
7 into the shaft 16 of the wand assembly 10, as shown in FIGS. 2,
5, 7, and 9. The cover 9 of the handle 2 may be configured to
detach from the swab 7 after the swab 7 is fully inserted into the
shaft 16 of the wand assembly 10. When the cover 9 is removed, the
swab 7, with the absorbent material 3, chamber 5 and sample tube 6
remain attached to the wand assembly 10.
[0039] As can be seen in FIG. 2, the chamber 5 may include chamber
vents 17. The chamber vents 17 may be sealed when the swab 7 is
fully inserted into the shaft 16 of the wand assembly 10.
[0040] As can be seen in FIG. 15c, the grip 14 of the wand assembly
10 is extendable. A user may extend the grip 14 of the wand
assembly 10 after the cover 9 is detached from the swab 7 and used
to whip the apparatus 1 up and down. The whipping action enables a
buffer to mix with a sample and stabilized reagent 4. The whipping
action allows the mixed sample to flow through the chamber 5 and
into the sample tube 6. The grip 14 may be retracted after
whipping.
[0041] The stand 15 is configured to attach to or engage with a
slot in a hand-held detector. When the apparatus 1 is attached to a
hand-held detector by the stand 15, the sample tube 6 is inserted
into a slot for further analysis of the prepared sample.
[0042] The apparatus 1 may be constructed of a suitable size and
weight so that it may be easily transported for use in the field.
For example, the apparatus 1 may be carried in the operator's hand
for simple portability.
[0043] FIGS. 9-14 show an alternative embodiment in which, an
apparatus 50 further includes a waste container 51 removably
attached to a tube 59. The tube 59 includes a port 53 for the
introduction of a liquid sample and a plunger 52 inserted into the
tube 59 for pushing the liquid sample into the waste container
51.
[0044] A safety clip 54 may be removably attached to the plunger
52. The safety clip 54 is configured to clip onto the plunger 52 to
prevent the plunger 52 from depressing prior to introduction of a
liquid sample into the port 53. The safety clip 54 may be removed
after a liquid sample is introduced into the port 53 to be prepared
for analysis.
[0045] A shown in FIGS. 12 and 13, the waste container 51 further
includes a well 55 for attaching the tube 59 to the waste container
51.
[0046] As shown in FIG. 11, the plunger 52 includes a buffer
compartment 58. The buffer compartment 58 is at an end of the
plunger 52. A spike 61 is positioned in the tube 59 and configured
to rupture the buffer compartment 58 when the plunger 52 is
depressed. When the buffer compartment 58 is ruptured, a buffer is
released to wash inhibitors off particles of a liquid sample. The
buffer (not pictured) washes the inhibitors off and passes through
a filter 56 and into the waste container 51.
[0047] The filter 56 is positioned inside the well 55 and
configured to receive a buffer and the liquid sample and collect a
portion of the prepared liquid sample.
[0048] The tube 59 and plunger 52 may be detached from the waste
container 51 and discarded.
[0049] The waste container 51 may include a material, such as
Watersorb, to absorb the waste liquid sample that passes through
the filter 56.
[0050] As can be seen in FIG. 14, the well 55 of the waste
container 51 is configured to receive a swab 107 of a handle 102.
The swab 107 is inserted into the well 55 and collects a specimen
of the prepared liquid sample.
[0051] The sample is collected on the absorbent material 103 and is
prepared for analysis as described in the previous embodiment,
FIGS. 1-8.
[0052] The waste container 51, as shown in FIGS. 9-14, may include
a vent 60. The waste container 51 may also include a handgrip 57
configured to be handled by a gloved hand.
[0053] The apparatus 50 may be constructed of a suitable size and
weight so that it may be easily transported for use in the field.
For example, the apparatus 50 may be carried in the operator's hand
for simple portability.
[0054] Given the disclosure of the present invention, one versed in
the art would appreciate that there may be other embodiments and
modifications within the scope and spirit of the invention.
Accordingly, all modifications attainable by one versed in the art
from the present disclosure within the scope and spirit of the
present invention are to be included as further embodiments of the
present invention. The scope of the present invention is to be
defined as set forth in the following claims.
* * * * *